NCT01756131

A Single Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Intramuscular and Subcutaneous Long Acting GSK1265744 in Healthy Subjects

An Observer- and Subject-Blinded, Randomized, Placebo-Controlled, Single Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Intramuscular and Subcutaneous Long Acting GSK1265744 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A single dose escalation study to determine the safety, tolerability, and pharmacokinetic profile of intramuscular and subcutaneous injections of GSK1265744 long acting parenteral (LAP) in healthy subjects. This study consists of a screening visit, a single injection, and follow-up evaluations for a minimum of 12 weeks following the injection.

Detailed description

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship

Conditions

• Infections, Human Immunodeficiency Virus and Herpesviridae

Interventions

Type	Name	Description
DRUG	GSK1265744 injectable suspension	200 milligram per milliliter sterile solution for injection
OTHER	Placebo to match injectable suspension	placebo

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-12-25
• Last updated: 2013-05-20